Expert Tips

10 Tips for Translational Stem Cell Therapy Research

Preclinical studies of stem cell therapies are critical for FDA approval to begin clinical trials, but there currently are no guidelines that address this important area of preclinical research. Here are some tips to consider when designing translational cell therapy research:

Ensure each step in the program is customized to the particular cell line, its actions, and the intended clinical use.

Understand the cell product. Cell products must be well-characterized with established production processes, detection methods, and characterization specifications before the initiation of preclinical studies and must be the same as the product to be used in clinical trials.

Animal models must be both clinically relevant and appropriate for preclinical study objectives.

Animal model selection must consider biological relevance, activity, persistence, and migration/distribution, and all must be relevant to clinical use.

Specialized animal models may be required (e.g., animal models for the targeted disease or the use of a specific immunocompromised model).

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.

If you have any questions about your subscription, click
hereto email us or call at (914) 740-2189.

You may also be interested in subscribing to the GEN magazine, an indispensable
resource for everyone involved in the business of translating discoveries at the
bench into solutions that fight disease and improve health, agriculture, and the
environment. Subscribe
today to see why over 60,000 biotech professionals read GEN to
keep current in the areas of genomics, proteomics, drug discovery, biomarker discovery,
bioprocessing, molecular diagnostics, collaborations, biotech business trends, and
more.